An ostomy appliance is a device used to collect waste material that exits a person's body through a stoma. The term "stoma" refers to the surgically created hole in the skin and the attached end of the bladder, conduit, or intestine. The stoma provides an open conduit through which a constant or intermittent efflux of waste material occurs. The surrounding skin area is termed the "peristomal area." A great challenge exists to comfortably and reliably connect an ostomy appliance to the peristomal area.
Sticky pressure sensitive adhesive tapes may be used for securing ostomy pouches to a patient. In one type of ostomy appliance the tapes are permanently bonded to the ostomy appliance. The ostomy appliance is used once and spent upon removal of the tape from the body.
A "two-piece" ostomy appliance may also be used. A first part is adhesively attached to the skin area around the stoma and has a snap ring of plastic that mates with a complementary snap ring on the separate ostomy device. When the two parts are snapped together, the rings form a leak-tight seal around the stoma and attach the bag to the patient. Unfortunately, however, the plastic rings are quite bulky and uncomfortable.
Other quick close/quick release mechanical fasteners are known. They may be repeatedly closed and opened and are frequently referred to as being reclosable. One such fastener, known as a hook and loop fastener, is available from Velcro U.S.A., Inc., Manchester, New Hampshire. Another such fastener, known as a mushroom-shaped fastener, is sold as the DUAL LOCK Reclosable Fastener by 3M Company, St. Paul, Minn. Both of these fasteners have certain undesirable characteristics for use in ostomy applications. For example, the hook or mushroom portions of the fasteners tend to snag fabric. Moreover, both the hook and loop portions of the fasteners tend to collect lint and dust. Also, these types of fasteners generally do not exhibit a thin profile, which may detract from an aesthetic appearance, or may not provide a liquid or odor tight seal. Another feature of the hook and loop fastener is that it makes noise when it is opened. This makes it undesirable in any application where noise is a concern.
Other known fastening systems, such as single or double sided tacky adhesive tapes also have various limitations. These limitations include non-recyclability, undesired transfer of the adhesive to a contact surface, and a tendency to irreversibly lose their adhesive properties when contaminated with lint or dust. Also, tacky adhesives tend to aggressively stick to latex surgical gloves which makes them hard to handle.
A great need exists for a reliable and inexpensive fastening system that is suitable for comfortably securing a medical device to a patient's skin.